Everolimus as Second-line Therapy in Metastatic Renal Cell Carcinoma (RECORD-4)
This study is currently recruiting participants.
Verified December 2012 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01491672
First received: December 12, 2011
Last updated: December 19, 2012
Last verified: December 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This study will evaluate everolimus as second-line therapy in patients with metastatic renal cell carcinoma. Each patient will be enrolled in one of three cohorts based upon their first-line therapy: 1) prior cytokines, 2) prior sunitinib, or 3) prior anti-VEGF therapy other than sunitinib.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Renal Cell Carcinoma |
Drug: RAD001 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label, Multicenter Phase II Study to Examine the Efficacy and Safety of Everolimus as Second-line Therapy in the Treatment of Patients With Metastatic Renal Cell Carcinoma |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Progression-free survival in patients who receive everolimus as second-line treatment for metastatic renal cell carcinoma [ Time Frame: 24 months ] [ Designated as safety issue: No ]To assess the duration of progression-free survival (PFS) during second-line treatment, defined as the time from the date of enrollment to the date of the first documented disease progression or death due to any cause. The PFS will be based on the local radiological data according to the RECIST 1.0 Criteria.
Secondary Outcome Measures:
- Safety profile of everolimus for the overall study population as well as for each first-line treatment cohort. [ Time Frame: 24 months ] [ Designated as safety issue: No ]The assessment of safety will be based mainly on the frequency of adverse events and on the number of laboratory values that fall outside of pre-determined ranges.
- Progression-free survival separately for each first-line treatment cohort [ Time Frame: 24 months ] [ Designated as safety issue: No ]Kaplan-Meier product-limit estimate of the PFS survival function as well as the median PFS along with it's 95% confidence interval will be displayed on the FAS separately for each first-line treatment cohort.
- Overall survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]The time from date of enrollment to date of death due to any cause.
- Clinical Benefit Rate (CBR) [ Time Frame: 24 months ] [ Designated as safety issue: No ]The proportion of patients with best overall response of CR or PR or stable disease based on the local radiological data according to the RECIST 1.0 Criteria.
- Objective Response Rate (ORR) [ Time Frame: 24 months ] [ Designated as safety issue: No ]The proportion of patients with best overall response of CR or PR based on the local radiological data according to the RECIST 1.0 Criteria
- Duration of Response (DoR) [ Time Frame: 24 months ] [ Designated as safety issue: No ]The duration of response will also be calculated for each first-line treatment cohort, and is defined as the time from the first occurrence of PR or CR (as per local radiological review) until the date of the first documented disease progression or death due to underlying cancer.
| Estimated Enrollment: | 201 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Everolimus
oral
|
Drug: RAD001 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Advanced renal cell carcinoma of a histological or cytological confirmation of clear cell (or with a component of clear cell) renal carcinoma that have previously progressed on or were intolerant to first-line therapy with sunitinib, sorafenib, pazopanib, axitinib, bevacizumab, or cytokine therapy.
- Prior nephrectomy (partial or total)
- Patients with at least one measurable lesion at baseline as per the RECIST 1.0 criteria
- Karnofsky Performance Status ≥ 70%
Exclusion Criteria:
- Patients who have received more than one prior treatment regimen for metastatic renal-cell carcinoma
- Patients who have received adjuvant therapy for RCC
- Patients who have previously received systemic mTOR inhibitors (eg, sirolimus, temsirolimus, everolimus)
- Patients with brain metastases
- Patients within 4 weeks post-major surgery, open biopsy, or significant traumatic injury to avoid wound healing complications.
- Patients who had radiation therapy within 4 weeks prior to start of study treatment (palliative radiotherapy to bone lesions allowed up to 2 weeks prior to study treatment start).
- Concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01491672
Contacts
| Contact: Novartis Pharmaceuticals | +1(800)340-6843 |
Locations
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10021 | |
| Contact 212-639-7762 | |
| Principal Investigator: Robert J. Motzer | |
| Argentina | |
| Novartis Investigative Site | Not yet recruiting |
| Rio Negro, Viedma, Argentina, 8500 | |
| Novartis Investigative Site | Recruiting |
| Tucuman, Argentina, T4000 | |
| Brazil | |
| Novartis Investigative Site | Not yet recruiting |
| Florianopolis, SC, Brazil, 88034-000 | |
| Novartis Investigative Site | Not yet recruiting |
| Barretos, SP, Brazil, 14784-400 | |
| Novartis Investigative Site | Not yet recruiting |
| Campinas, SP, Brazil, 13083-970 | |
| Novartis Investigative Site | Not yet recruiting |
| São Paulo, SP, Brazil, 01246-000 | |
| Novartis Investigative Site | Not yet recruiting |
| São Paulo, SP, Brazil, 01509-900 | |
| China, Guangdong | |
| Novartis Investigative Site | Withdrawn |
| Guangzhou, Guangdong, China, 510080 | |
| China, Jiangsu | |
| Novartis Investigative Site | Not yet recruiting |
| Nanjing, Jiangsu, China, 210029 | |
| China, Zhejiang | |
| Novartis Investigative Site | Recruiting |
| Hangzhou, Zhejiang, China, 310003 | |
| China | |
| Novartis Investigative Site | Recruiting |
| Beijing, China, 100021 | |
| Novartis Investigative Site | Not yet recruiting |
| Beijing, China, 100730 | |
| Novartis Investigative Site | Not yet recruiting |
| Guangzhou, China, 510060 | |
| Novartis Investigative Site | Recruiting |
| Shanghai, China, 200032 | |
| Russian Federation | |
| Novartis Investigative Site | Not yet recruiting |
| Leningrad Region, Russia, Russian Federation, 188663 | |
| Novartis Investigative Site | Not yet recruiting |
| Moscow, Russia, Russian Federation, 125284 | |
| Novartis Investigative Site | Not yet recruiting |
| Nizhny Novgorod, Russia, Russian Federation, 603001 | |
| Novartis Investigative Site | Not yet recruiting |
| Obninsk, Russia, Russian Federation, 249036 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01491672 History of Changes |
| Other Study ID Numbers: | CRAD001L2404, 2010-020447-13 |
| Study First Received: | December 12, 2011 |
| Last Updated: | December 19, 2012 |
| Health Authority: | United States: Food and Drug Administration Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Brazil: Associação Fundo de Incentivo à Pesquisa Bulgaria: Ministry of Health China: Food and Drug Administration Denmark: Danish Medicines Agency |
Keywords provided by Novartis:
|
Metastatic Renal Cell Carcinoma Second Line Everolimus RAD001 |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases |
Everolimus Sirolimus Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 21, 2013